Real-World Efficacy and Safety Analysis of Omadacycline for the Treatment of Diabetic Foot Infections and Acute Osteomyelitis

October 17, 2023 updated by: Methodist Health System

This will be a prospective, open-label, two-center study to assess the safety of omadacycline use in the treatment of hospitalized subjects with moderate to severe DFI with or without Acute osteomyelitis (AOM) who are at a high risk for development of CDI, AKI, and/or resistant pathogens compared to retrospective controls. Prospective enrollment will be continued until the sample size is achieved up to one year from start date (October 2020).

Secondary to slower than anticipated enrollment due to the COVID-19 pandemic and initial exclusion of AOM, following protocol amendment, patient enrollment will be continued until the sample size is achieved up to 18 months from amendment approval (anticipate April 2022 - October 2023). A historical matched case cohort (standard of care) at the two hospitals based on ICD10 codes associated with DFI [E11.(621, 622), E10.(621, 622); L97.(509, 521, 522, 523, 524, 529)], including subjects with AOM [M86.(08-09, 10, 16-19, 8X0, 8X7-8X9, 9) will be utilized for comparison.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a year-long study with planned enrollment of 57 patients (in addition to 114 historical control patients) evaluating the use of omadacycline for treatment of diabetic foot infections (DFI). Omadacycline (Nuzyra®) is a FDA approved antibiotic for skin and skin structure infection and community-acquired pneumonia. This study is considered to be investigational because data is being collected on the use of Omadacycline for the treatment of DFI with or without AOM.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75203
        • Recruiting
        • Methodist Dallas Medical Center
        • Contact:
        • Principal Investigator:
          • Matthew Crotty, PharmD
      • Dallas, Texas, United States, 75237
        • Not yet recruiting
        • Methodist Charlton Medical Center
        • Principal Investigator:
          • Matthew Crotty, PharmD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult diabetic with DFI hospitalized, 18 years or older, diagnosed with type 1 or 2 diabetes, and have DFI with or without AOM

Description

Inclusion Criteria:

  • Female and male subjects will be eligible for inclusion if hospitalized, 18 years or older, diagnosed with type 1 or 2 diabetes, and have DFI with the additional clinical criteria as specified below:

    • Acute infection or worsening without systemic antimicrobials within the previous 14 days
    • At least one full or partial thickness-infected ulcer at or below the ankle AND
    • Purulent drainage OR

    • Two of the following:

      • Erythema
      • Local edema
      • Fluctuance
      • Induration
      • Increased local warmth
      • Fever
    • No systemic antimicrobials with current hospital admission for more than 48 hours prior to enrollment

  • Inclusion will be based on

    • Empiric coverage based on organisms suspected to be caused by susceptible bacteria, if no culture identifies a specific organism; or

    • Confirmed susceptibility to omadacycline against any organism identified. Any subject in which a pathogen resistant to omadacycline is identified will be excluded from the study and antibiotics will be changed based on physician discretion.

      • First episodes of AOM at qualifying site of infection will be eligible for inclusion with any of the following criteria confirming the diagnosis:

        • Imaging (X-ray or MRI) confirmation of acute osteomyelitis
        • Pathology (bone biopsy/culture)
      • Not currently enrolled in any other clinical trial
      • Provides informed consent
      • Likely to be compliant with all study-related procedures and visits

Exclusion Criteria:

  • Age less than 18 years
  • Pregnant women

  • Chronic osteomyelitis

    • Osteomyelitis of the same site previously treated with antibiotics
    • Documented presence of osteomyelitis more than 2 weeks prior to index admission
    • Necrotic or dead bone identified by pathology
    • Unclear chronicity of infection (if unable to determine acute osteomyelitis)
  • Has any gangrenous ulcers or necrotizing fasciitis
  • Has a pathogen known to be resistant to omadacycline
  • Administration of additional systemic antibiotics in combination with omadacycline, not including topical routes or oral vancomycin/fidaxomicin given their local activity within the GI tract
  • Contraindication or hypersensitivity to omadacycline/tetracyclines
  • Unwilling or unable to participate in study-related procedures or visits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retrospective Cohort
A historical matched case cohort
Prospective Cohort
Subjects will be screened daily via review of the EMR reports of inpatient admissions. Those receiving antibiotics with a notated source of skin/soft tissue infection or OM will be further reviewed to determine if the source of infection is a DFI with or without suspected or confirmed Acute osteomyelitis.
Drug: Omadacycline
Omadacycline monotgherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AKI based on RIFLE criteria
Time Frame: Sept 2020 - Aug 2021
Risk, injury, failure, loss and ESRD
Sept 2020 - Aug 2021
Clostridioides difficile Infection
Time Frame: Sept 2020 - Aug 2021
Frequency of Clostridioides difficile Infections while taking Omadacycline compared to other antibiotics
Sept 2020 - Aug 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Methodist Health System

Investigators

  • Principal Investigator: Matthew Crotty, PharmD, Methodist Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2020

Primary Completion (Actual)

August 18, 2023

Study Completion (Estimated)

August 18, 2024

Study Registration Dates

First Submitted

January 14, 2021

First Submitted That Met QC Criteria

January 14, 2021

First Posted (Actual)

January 19, 2021

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 014.PHA.2020.A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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